MAUDE Adverse Event Report: IMTMEDICAL AG BELLAVISTA; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number BELLAVISTA 1000 US

Device Problem Mechanical Problem (1384)

Patient Problem Pneumothorax (2012)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.However, log files has been sent by the customer and being reviewed by technical support.No root cause has been determined at this time since the investigation is still ongoing.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported bellavista 1000 us occlusion alarm constantly alarming while on a patient.The patient got pneumothorax and transferred to a higher level neonatal intensive care unit (nicu) after this event.

Manufacturer Narrative

Device evaluation update: g3, g6, h2, h6 and h10.Results of investigation: the suspect device was not returned for investigation.After installed of the new upgraded software v6.0.1600.0 and full unit preventive maintenance, no failure has been detected.Vyaire medical was unable to established the exact root cause as there is no longer signs of technical issue.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 11125625
• MDR Text Key: 226083256
• Report Number: 3004553423-2020-00752
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149388183
• UDI-Public: (01)07640149388183(11)20190930
• Combination Product (y/n): N
• PMA/PMN Number: K163127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BELLAVISTA 1000 US
• Device Catalogue Number: 301.100.030
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention